ISO 11607-1 2006 Reference

Kimberly-Clark*
Kimguard* Sterilization Wrap .
Compliance to
ISO 11607-1:2006
The manufacturer, Kimberly-Clark, does not accept any responsibility for the incorrect choice or misuse
of the product shown in this brochure. All information contained in this brochure is as accurate as
possible at the time of publication, however legislation and regulations are under constant review and
may change in the lifetime of this brochure. Accordingly the specification for the product may be subject
to change.
Kimberly-Clark*
Kimguard* Sterilization Wrap
Table of contents: Compliance to ISO 11607 1; 2006
Introduction
1. General requirements

1.1 Quality systems

1.2 Sampling
1.3 Test methods
1.4 Documentation
2. Materials and preformed sterile barrier systems

2.1 General requirements

2.2 Microbial barrier properties
2.3 Compatibility with the sterilization process
2.4 Compatibility with the labeling system
2.5 Storage and transport
Appendix 1: ISO 9001

Appendix 2**: Physical properties
Appendix 3**: Chemical properties
Appendix 4**: Ethylene oxide sterilant penetration and residuals study results for Kimguard* and

Kimguard One-Step* sterilization wrap
Appendix 5**: Pre-vacuum steam sterilant penetration study results for Kimguard* and Kimguard
One-Step* sterilization wrap
Appendix 6**: Basis weight of materials not requiring conditioning
Appendix 7**: Executive summary colorfastness study for Kimguard One-Step* sterilization wrap
Appendix 8**: Maintenance of package integrity study results for Kimguard* and Kimguard One-Step*

sterilization wrap
** Prepared by H. Prokash, Senior Research
Kimberly-Clark*
Kimguard* Sterilization Wrap
List of used acronyms and abbreviations
C :
degree Celsius
AAMI :
Association for the Advancement of Medical Instrumentation
AATCC : American Association of Textile Chemists and Colorists

ANSI :
American National Standards Institute
ASTM : American Society for Testing and Materials

AVG BW : Average Basis Weight
BFE :
Bacterial Filtration Efficiency
BI :
Biological Indicator
CD tear : Cross Direction

cm2 :
Square centimeter
CV :
Coefficient of Variation
DIN :
Deutsches Institut fr Normung
ECH :
Ethylene Chlorohydrin
EN :
European Norm
EO :
Ethylene Oxide
F:
Fahrenheit
FIFO :
First In First Out
FTMS :
in2 :
Flexible Test and Measurement System
INDA :
International Nonwovens and Disposables Association
ISO :
International Organization for Standardization
IST :
International Standard Test
kg :
Kilogram
l:
Liter
lbs :
m2:
Pounds
mbar :
milibar
Square inches
Square meter
MD tear : Machine Direction

mg :
Miligram
ml :
Mililiter
NFPA :
National Fire Prevention Association
pH :
Measure of the acidity or alkalinity
PVC :
Polyvinyl chloride
RH :
Relative Humidity
SAL :
Sterility Assurance Level
SBS :
Sterile Barrier System
sec :
Seconds
SOPs :
Standard Operating Procedures
STD :
UV :
Standard Deviation
Ultraviolet
Kimguard* Sterilization Wraps

Compliance to ISO 11607-1:2006
Introduction
Kimguard* and Kimguard One-Step* meet the global standard for Sterile Barrier Systems (SBS): EN ISO 11607-1
and EN ISO 11607-2
The harmonization of ISO 11607 and EN 868-1 is complete, and the new Global Standard for SBSEN ISO 116071 and EN ISO 11607-2is in place. We at Kimberly-Clark* want to assure you that the KIMGUARD* Sterilization
Wrap you have relied on for years for its:

High strength
Effective barrier
Low lint
Easy aseptic presentation
fully complies with both parts of the new standard. Part 1 replaces EN 868-1 and specifies general requirements
for all SBS. Part 2 describes the validation requirements for forming, sealing, and assembly processes of SBS.
So you can continue to use KIMGUARD* Sterilization Wrap, including KIMGUARD ONE-STEP* Simultaneous
Wrap and KIMGUARD* Sequential Wrap, with confidence.
The following document should resolve most of your questions. However, if you do have additional questions,
please contact your local Kimberly-Clark sales representative.
1. General requirements
1.1 Quality systems
1.1.1 The activities described in this part of ISO 11607-1:2006
KIMGUARD* products are manufactured in our facilities in Linwood, North Carolina. This facility is certified by
the following documents:

See appendix 1: ISO 9001:2008 Certificate
1.2 Sampling
All testing relative to compliance to ISO 11607-1 was conducted on product randomly selected from distribution
and thus representative of normal variations.
1.3 Test methods

1.3.1 All test methods used to show compliance with this International Standard shall be validated and documented.
Kimberly-Clark*
Test method
Test
ISO 6588, hot extraction method
Colour leach
ASTM 3776-07
Grammage
INDA Standard test IST 160.1 (01)
Gelbo Lint
EN 21974
MD Tear
EN 21974
CD Tear
ISO 2758
Bursting Strength (dry)
ISO 3689
Bursting Strength (wet)
EN ISO 1924-2
Elongation (MD)
EN ISO 1924-2
Elongation (CD)
EN ISO 1924-2
MD Tensile Strength (dry)
EN ISO 1924-2
CD Tensile Strength (dry)
ISO 3781
MD Tensile Strength (wet)
ISO 3781
CD Tensile Strength (wet)
ISO 6588-2, hot extraction method
pH
ISO 9197-1, hot extraction method
Sodium Chloride content
ISO 9198, hot extraction method
Sodium Sulphate content
DIN 58953-6:1987
Fluorescence
5514 FTMS No. 191A, INDA 80.4 -92
Hydrostatic Head Pressure
ASTM F2101
Bacterial Filtration Efficiency
1.3.2 Test method validation shall demonstrate the suitability of the methods as used. The following

elements shall be included:

establishment of a rationale for the selection of the appropriate tests for the packaging system;
establishment of acceptance criteria;
determination of test method repeatability;
determination of test method reproducibility;
establishment of test method sensitivity for integrity tests.
This information is documented in our Design Control system and also in specific test methods.
1.3.3 Unless otherwise specified in the test methods, test samples shall be conditioned at 23 ( 1)C

and 50 ( 2)% relative humidity for a minimum of 24 h.
All test results were conditioned at 23C and 50% RH. The BFE method calls for different conditioning
parameters, so the parameters specified in the method were used. All other tests were conditioned per
the requirements of the specific method.
Kimberly-Clark*
1.4 Documentation
1.4.1 Demonstration of compliance with the requirements of this part of ISO 11607 shall be documented.
1.4.2 All documentation shall be retained for a specified period of time. The retention period shall consider factors

such as regulatory requirements, expiry date and traceability of the medical device or sterile barrier system.
The Kimberly-Clark* Corporate Records Retention procedures are followed, which currently state a Lot and
batch record retention period of 10 years from the production date.
2. Materials and preformed sterile barrier systems

2.1 General requirements
2.1.1 The conditions under which the material and/or preformed SBS are produced and
handled shall be established, controlled and recorded in order to ensure that:
a) the conditions are compatible with the use for which the material and/or SBS are designed
b) the performance characteristics of the material and/or SBS are maintained
2.1.2 As a minimum, the following shall be considered:
a) temperature range
The warnings in the directions for use state:
A temperature of 143C (290F) should not be exceeded during sterilization.
When utilizing a 100% EO sterilization cycle with a concentration of 725-735 mg/L at 55C (131F)

and 40% - 80% relative humidity for 60 minutes with the KIMGUARD* wrap, do not sterilize at a set point
below 55C (131F).

See paragraph 2.5.2. for the ideal temperature range immediately prior to use.
b) pressure range
KIMGUARD* products are not impacted by variations in pressure differences during normal conditions of use.
c) humidity range
EO sterilization should be performed at 40% - 80% relative humidity.

See paragraph 2.5.2 for the ideal humidity range immediately prior to use.
d) maximum rate of change of the above, where necessary

KIMGUARD* products are not impacted by changes in temperature, pressure or humidity during normal conditions
of use.
e) exposure to sunlight or UV light
KIMGUARD* SBS are not to be exposed to fluorescent or UV light.
f) cleanliness
No significant amount of particulate matter or linting was observed during normal use.

See paragraph 2.1.5.d.
g) bioburden
During the whole manufacturing process, environmental conditions are controlled and bio-burden is monitored.
As the sterilant penetration and post-sterilization shelf life studies were successfully completed on random
Kimberly-Clark*
lots of wrap, it was proven that existing bioburden levels on the wrap are not an issue for sterilization.
h) electrostatic conductivity
KIMGUARD* wraps are treated with less than 0.009% by weight of a potassium phosphate anti-static treatment.
2.1.3 The source, history and traceability of all materials, especially recycled materials, shall be known and

controlled to ensure that the finished product will consistently meet the requirements of this part of ISO 11607.
The source, history and traceability of all materials are controlled by the internal quality systems.
2.1.4 The following properties shall be evaluated:
a) microbial barrier (see 2.2)
The microbial barrier function of the KIMGUARD* sterilization wraps was validated using the BFE test.

See appendix 2: Physical properties
b) biocompatibility and toxicological attributes

KIMGUARD* and KIMGUARD ONE-STEP* sterilization wrap products have been evaluated for biocompatibility.
Test samples from final finished sterilized (EO, gravity steam, and pre-vacuum steam) wrap material were
evaluated for in vitro cytotoxicity, in vivo dermal irritation, and dermal sensitization potential. Results from
these studies were acceptable and did not show any sign of toxicity. Additional human subject and in vitro
studies support these results.
When used as directed, KIMGUARD* and KIMGUARD ONE-STEP* sterilization wrap products have a
wide margin-of-safety for users or patients and can be considered essentially non-toxic. This statement
is based on the assessment of the safety profiles of raw materials used to manufacture KIMGUARD*
and KIMGUARD ONE-STEP* sterilization wrap products in combination with analytical and flammability
results and the lack of observed adverse effects in the biocompatibility testing battery conducted with
samples of finished product sterilized under EO, pre-vacuum steam or gravity steam conditions
c) physical and chemical properties
All physical and chemical properties referenced in appendix 2 and 3 are included in EN 868-2:2009.


See appendix 3: Chemical properties
d) compatibility with respect to forming and sealing processes

KIMGUARD* has been used for over 20 years and has demonstrated to have excellent drapeability that conforms
to equipment pack contours smoothly and closely.
e) compatibility with respect to the intended sterilization process(es) (see 2.3)
The physical properties of the wrap were tested both pre-sterilization and post-sterilization with steam and EO
and the design specifications were met in all cases.

See appendix 4: EO sterilization

See appendix 5: pre-vacuum steam sterilization
Kimberly-Clark*
f) any shelf-life limitations for pre-sterilization and post-sterilization storage

Healthcare facilities may use established event- and/or time-related protocols to monitor sterility
maintenance of packages wrapped with the KIMGUARD* and KIMGUARD One-Step* Sterilization Wraps
in accordance with accepted standards of practice. Real-time testing simulating clinical use supports
maintenance of package sterility for at least 30 days; however, this time-point does not prevent facilities from
continuing to use established healthcare facility protocols.
The pre-sterilization shelf life of KIMGUARD* products is 5 years.
2.1.5 Materials, e.g. wrapping materials, paper, plastic film, nonwovens or reusable fabrics, shall meet the

following general performance requirements.
a) Materials shall be non-leaching and odourless under specified conditions of use, to such an extent that
neither performance nor safety is impaired and the medical devices with which they are in contact are not
adversely affected.
KIMGUARD* wraps do not show any color leach as tested with ISO 6588, hot extraction method. KIMGUARD*
wraps are odourless under normal conditions of use.

b) Materials shall be free of holes, cracks, tears, creases or localized thickening and/or thinning sufficient to
impair functioning.
The manufacturing facilities use standard operating procedures (SOPs) to routinely inspect for holes and other
visual issues and to correct any issues that may arise, with the goal that customers receive product that is free
of defects that could impair the wraps intended use. Additionally, users are instructed to examine the wrap
prior to use and to discard if damage or extraneous matter is detected.
c) Materials shall have a basis weight (mass per unit area) which is consistent with the specified value.
The KIMGUARD* Sterilization wraps do not show significant variations in basis weight. Grammage was determined
based on ASTM 3776-07.

See appendix 6: Basis Weight of Materials Not Requiring Conditioning
d) Materials shall exhibit acceptable levels of cleanliness, particulate matter and linting.
KIMGUARD* wraps were tested with the GELBO lint test (IST 160.1 (01)). The test results show that the level
of linting/particulate matter/cleanliness stays well below Kimberly Clarks internal specifications.

e) Materials shall comply with established specific or minimum physical properties, such as tensile strength,
thickness variation, tear resistance, air permeance and burst strength.
All types of KIMGUARD* sterilization wraps comply with the specified physical properties as set out in EN 868-2: 2009.

f) Materials shall comply with established specific chemical characteristics (such as pH value, chloride, and
sulfate content) to meet the requirements of the medical device, packaging system or sterilization process.
All types of KIMGUARD* sterilization wraps comply with the specified chemical characteristics as set out in
EN 868-2: 2009.

Kimberly-Clark*
g) Materials shall not contain or release material known to be toxic in sufficient quantity to cause a health hazard
either before, during or after sterilization under the conditions of use.
The wrap material is composed of polypropylene with the addition of less than 2% by weight of phthalocyanine
blue pigment, less than 1% by weight of titanium dioxide pigment, and less than 0.009% by weight of a potassium
phosphate anti-static treatment.
KIMGUARD* and KIMGUARD ONE-STEP* sterilization wrap products have been evaluated for biocompatibility.
Test samples from final finished sterilized (EO, gravity steam, and pre-vacuum steam) wrap material were
evaluated for in vitro cytotoxicity, in vivo dermal irritation and dermal sensitization potential. Results from
these studies were acceptable and did not show any sign of toxicity. Additional human subject and in vitro
studies support these results.

See 2.1.4.b
2.1.6 In addition to the requirements given in 2.1.1 through 2.1.5, adhesive-coated materials shall meet the

requirements listed below.
a) Coating patterns shall be continuous without skips or breaks in the pattern sufficient to cause a discontinuity
in the seal.
KIMGUARD* wraps are not coated.
b) Coating mass shall be consistent with the stated value.
KIMGUARD* wraps are not coated.
c) Materials shall demonstrate minimum specified seal strength when a seal is formed with another specified
material under specified conditions.
KIMGUARD* wraps are not intended to be combined with other materials for use as an SBS.
2.1.7 In addition to the requirements given in 2.1.1 through 2.1.5 and, if appropriate, 2.1.8, sterile barrier systems

and preformed sterile barrier systems shall meet the requirements listed below.
a) Materials and components, e.g. coatings, ink or chemical indicators, shall not adversely affect the medical
device by reaction, contamination and/or transfer before, during or after the defined sterilization process.
There was no change in the colorfastness of the ink caused by the sterilization cycles.

See appendix 7: Executive Summary Colorfastness Study for KIMGUARD ONE-STEP* Sterilization Wrap
b) If formed by sealing, the specified requirements for seal width and seal strength (tensile and/or burst) shall
be met.
Not applicable.
c) Peel-open characteristics shall be continuous and homogeneous, without delamination or tearing of the
material that can affect aseptic opening and presentation.
Not applicable.
d) Seals and/or closures shall provide a barrier to microorganisms.
The method of wrapping provides a tortuous path, which is a barrier to microorganisms. This was demonstrated
via maintenance of package integrity testing.
See appendix 8: Maintenance of Package Integrity Study Results for KIMGUARD* and KIMGUARD ONE- STEP*

Sterilization Wrap
Kimberly-Clark*
2.1.8 In addition to the requirements given in 2.1.1 through 2.1.5, reusable containers shall meet the requirements

given below.
Not applicable
2.1.9 In addition to the requirements given in 2.1.1 through 2.1.5 and if appropriate, 2.1.8, reusable fabrics
shall meet the requirements given below:
KIMGUARD* sterilization wraps are non-wovens intended for single use.
2.2 Microbial barrier properties

2.2.1 The impermeability of a material shall be determined in accordance with Annex C.
KIMGUARD* is not impermeable. However, it has demonstrated excellent microbial barrier properties.
2.2.2 Demonstrating that the material is impermeable shall satisfy the microbial barrier requirement.
KIMGUARD* is not impermeable.
2.2.3 Porous materials shall provide an adequate microbial barrier to microorganisms in order to provide integrity

of the sterile barrier system and product safety.
KIMGUARD* wraps show excellent microbial barrier properties as demonstrated in the bacterial filtration efficiency
test performed as per ASTM F2101.

2.3 Compatibility with the sterilization process

2.3.1 It shall be demonstrated that the materials and preformed SBS are suitable for use in the specified
sterilization process(es) and cycle parameters.
The KIMGUARD* Sterilization wraps have successfully passed the sterilant penetration tests for both Steam
and EO.

See paragraph 2.1.4 e.
2.3.2 Sterilization compatibility should be determined using a sterilizer designed, constructed and operated in

accordance with the requirements of the relevant International or European Standards.
Testing was performed at Nelson Laboratories (Salt Lake City, Utah) in accordance with the Good Laboratory
Practice regulations. The EO sterilizers used in this facility comply to EN ISO 11135-1:2007 and EN ISO 17665-1:2006.
2.3.3 The performance of the materials shall be evaluated to ensure that the material performance remains

within specified limits after exposure to all the specified sterilization processes.
KIMGUARD* wrap was tested and met specifications for strength, barrier and lint both before and after sterilization
by pre-vacuum steam at 132C (270F) for 4 minutes with a 20 minute dry time or by EO (100% EO with a
concentration of 725 mg/L at 54-55C and 40% - 80% relative humidity for 60 minutes and subsequent aeration).

See paragraph 2.1.5.e.
Kimberly-Clark*
2.3.4 Determination of suitability for the intended purpose shall include consideration of material variations

that will occur during normal routine supply.
All testing was conducted on products randomly selected from distribution and thus representative of normal
variations.
2.3.5 Where the product is enclosed by multiple wrappings or layers, different limits on material properties may

be set for inner and outer layers.
The sterile barrier system of KIMGUARD* always consists of 2 layers of nonwoven wrap. Whether applied
simultaneous or sequential, wrapping techniques and the quality characteristics for both layers are identical.
2.4 Compatibility with the labeling system

The labeling system shall
a) remain intact and legible until the point of use
b) be compatible with the materials, sterile barrier system and medical device during and after the specified
sterilization process(es) and cycle parameters and shall not adversely affect the sterilization process, and
c) not be printed or written in ink of a type which can be transferred to the medical device nor react with the
packaging material and/or system to impair the utility of the packaging material and/or system, nor change
colour to an extent which renders the label illegible.
KIMGUARD ONE STEP* sterilization wraps should be labeled with the statement ONE-STEP Open Once
before use. KIMGUARD* is compatible with most sterilization closure tapes. Writing should not be applied
directly on the wrap.

See appendix 7: Executive Summary Colorfastness Study for KIMGUARD ONE-STEP* Sterilization Wrap
2.5 Storage and transport

2.5.1 Materials and preformed SBS shall be packaged to provide the protection necessary to maintain the

performance characteristics during transport and storage.
The wraps are packaged in plastic shrink wrap (to maintain wrap cleanliness) and are then placed in a shipping
case (to protect from ultraviolet light and damage during shipping/transport).
The transport packaging mentions the following information as per EN 868-2:2009:
a) reference number
b) quantity
c) manufacturer name and product name
d) date of manufacture
e) lot number
f) nominal sheet size in centimeters
g) the recommended storage conditions
2.5.2 Materials and preformed sterile barrier systems shall be transported and stored under conditions

that ensure that the performance characteristics remain within specified limits (see 2.1).

This can be accomplished by:
a) demonstrating retention of these characteristics under defined storage conditions, and
b) ensuring that storage conditions remain within specified limits.
Kimberly-Clark*
Storage Prior to Use:

Location should be
1) clean
2) dust free
3) away from fluorescent or ultraviolet light
Use FIFO stock rotation.
Prior to Use
Condition wraps at ideal temperature and humidity for a minimum of two hours.
Temperature 68F to 73F / 20C to 23C
Relative humidity ranging from 30% to 60%
Examine wrap and discard if damage or extraneous matter is detected.
Thoroughly clean and dry items to be wrapped/packaged
Kimberly-Clark*
Appendix 1: ISO 9001: 2000 Certificate
Kimberly-Clark*
Kimberly-Clark*
Appendix 2: Physical properties

Physical Properties Test Methodology and Results for KIMGUARD ONE-STEP*
KC100 Sterilization Wrap
Test
Methodology
Interpretation
of Results
KIMGUARD
ONE-STEP*
KC100
Sterilization
Wrap Results1
BFE
Staphylococcus aureus particles are aerosolized and

sprayed onto the fabric. Results are reported as percent
efficiency and correlate with the ability of the fabric
to resist bacterial penetration.2,3
Higher numbers
in this test indicate
better barrier
efficiency.
98.9 %4
Grab Tensile
Force is applied to the test fabric until the fabric Higher numbers
breaks. The force required to break the fabric - grab indicate a stronger
tensile load - is measured. Results are reported as fabric.
pounds of force required to break the fabric. The lower
result of CD or MD direction is reported.5
11.43 kg
(25.2 lbs)6
Resistance to
Linting
In a controlled environment, a 9"X9" sample of fabric

is clamped inside a Gelbo Dry Particle Generator. It
is then flexed one time every second for a period of
five minutes. Particles generated during the test period
are counted using a laser particle counter. Results are
expressed as the average number of lint particles
generated greater than 10 microns in size.7
Lower numbers
in this test indicate
less lint, which
is desirable in the
operating room
environment.
3 particles6
Hydrostatic
Pressure
The fabric sample is clamped onto the bottom of a

vertical column, into which water is poured. When
leakage is observed on the underside of the fabric,
the amount of water in the column is measured. Results
are expressed in millibar (mbar) of water pressure a
fabric can repel before leaking.8
A higher number
indicates greater
resistance to water
penetration.
59.5 mbar6
Flammability
The fabric sample is held at a 45 angle and a standardized

flame is applied to the bottom edge of the specimen
for 30 seconds or until sustained ignition occurs,
whichever comes sooner. Four classes are recognized
by the National Fire Prevention Association (NFPA)
for fabrics used for clothing:
Class 1: Slow burning fabrics which have a flame
spread time of 20 seconds or more.
Class 2: Moderately flammable fabrics which have a
flame spread time of 8 to 19 seconds inclusive.
Class 3: Relatively flammable fabrics which have a
Class 4: Dangerously flammable fabrics which have a
flame spread time of less than 3 seconds.
Results are reported by classification and seconds
until sustained ignition.9
A lower class Class 1 (30 sec.)6

(longer time)
indicates a more
flame resistant
fabric.
1 The
above results are averages based upon testing of representative samples selected randomly from distribution. Since KIMGUARD
ONE-STEP* sterilization wrap consists of two layers bonded together, all testing was conducted on two layers.
2 Nelson Laboratories, Inc., Salt Lake City, Utah, Bacterial Filtration Efficiency, Procedure No. SOP/ARO/007I.1.
3 ASTM F2101-07. Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a
Biological Aerosol of Staphylococcus aureus 2007.
Kimberly-Clark*
4 Test
data generated by Nelson Laboratories, Inc., Salt Lake City, Utah via lab # 421675.
ASTM D5034-95(2001). Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test) 2001.
6 Test data generated by Integrated Paper Services, Neenah, WI via request # 9051.
7 INDA Standard test IST 160.1:1995, Resistance to Linting of Nonwoven Fabrics, 1995.
8 AATCC 127-2003. Water Resistance: Hydrostatic Pressure Test 2003. Standard Test Method for Repellency of Nonwoven Fabrics
Using the Hydrostatic Pressure Test, IST 80.4, INDA Standard Tests.
9 NFPA 702-1980. Flammability of wearing apparel
.
5
Kimberly-Clark*

Test
Methodology
Interpretation
of Results
KIMGUARD
ONE-STEP*
KC200
Sterilization
Wrap Results1
BFE

Higher numbers in
this test indicate
better barrier
efficiency.
99.7 %4
Grab Tensile
13.2 kg
(29.1 lbs)6
Resistance to
Linting

is clamped inside a Gelbo Dry Particle Generator. It
is then flexed one time every second for a period of
five minutes. Particles generated during the test period
are counted using a laser particle counter. Results
are expressed as the average number of lint particles
Lower numbers in
this test indicate
less lint, which is
desirable in the
operating room
environment.
4 particles6
Hydrostatic
Pressure

A higher number
indicates greater
resistance to water
penetration.
77.4 mbar6
Flammability
The fabric sample is held at a 45 angle and a

standardized flame is applied to the bottom edge of
the specimen for 30 seconds or until sustained ignition
occurs, whichever comes sooner. Four classes are
recognized by the National Fire Prevention Association
(NFPA) for fabrics used for clothing:
Results are reported by classification and seconds until
sustained ignition.9
A lower class (longer Class 1 (30 sec.)6

time) indicates a
more flame resistant
fabric.
1 The
4 Test data generated by Nelson Laboratories, Inc., Salt Lake City, Utah via lab # 421674.
5 ASTM D5034-95(2001). Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test) 2001.
Kimberly-Clark*
6 Test
data generated by Integrated Paper Services, Neenah, WI via request # 9051.

INDA Standard test IST 160.1:1995, Resistance to Linting of Nonwoven Fabrics, 1995.
.
7
Kimberly-Clark*

Test
Methodology
Interpretation
of Results
KIMGUARD
ONE-STEP*
KC300
Sterilization
Wrap Results1
BFE

Higher numbers in
this test indicate
better barrier
efficiency.
99.9 %4
Grab Tensile
16.65 kg
(36.7 lbs)6
Resistance to
Linting

is clamped inside a Gelbo Dry Particle Generator. It is
then flexed one time every second for a period of five
minutes. Particles generated during the test period
Lower numbers in
this test indicate
less lint, which is
desirable in the
operating room
environment.
1 particles6
Hydrostatic
Pressure

A higher number
indicates greater
resistance to water
penetration.
85.2 mbar6
Flammability

Class 2: Moderately flammable fabrics which have a flame
spread time of 8 to 19 seconds inclusive.
Class 3: Relatively flammable fabrics which have a flame
Class 4: Dangerously flammable fabrics which have a flame
spread time of less than 3 seconds.

time) indicates a
more flame
resistant fabric.
1 The above results are averages based upon testing of representative samples selected randomly from distribution. Since KIMGUARD
Kimberly-Clark*
127-2003. Water Resistance: Hydrostatic Pressure Test 2003. Standard Test Method for Repellency of Nonwoven Fabrics
.
8 AATCC
Kimberly-Clark*

Test
Methodology
Interpretation
of Results
KIMGUARD
ONE-STEP*
KC400
Sterilization
Wrap Results1
BFE

efficiency and correlate with the ability of the fabric to
resist bacterial penetration.2,3
Higher numbers in
this test indicate
better barrier
efficiency.
99.9 %4
Grab Tensile
Resistance to
Linting

Lower numbers in
this test indicate
less lint, which is
desirable in the
operating room
environment.
1 particles6
Hydrostatic
Pressure
The fabric sample is clamped onto the bottom of a vertical

column, into which water is poured. When leakage is
observed on the underside of the fabric, the amount
of water in the column is measured. Results are
expressed in millibar (mbar) of water pressure a fabric
can repel before leaking.8
A higher number
indicates greater
resistance to water
penetration.
88.6 mbar6
Flammability

Class 3: Relatively flammable fabrics which have a flame

time) indicates a
fabric.
1 The
23.5 kg
(51.8 lbs)6
Kimberly-Clark*
AATCC 127-2003. Water Resistance: Hydrostatic Pressure Test 2003. Standard Test Method for Repellency of Nonwoven Fabrics
9NFPA 702-1980. Flammability of wearing apparel.
8
Kimberly-Clark*

Test
Methodology
Interpretation
of Results
KIMGUARD
ONE-STEP*
KC500
Sterilization
Wrap Results1
BFE

Higher numbers in
this test indicate
better barrier
efficiency.
99.9 %4
Grab Tensile
Force is applied to the test fabric until the fabric breaks. Higher numbers
The force required to break the fabric - grab tensile indicate a stronger
load - is measured. Results are reported as pounds of fabric.
force required to break the fabric. The lower result of
CD or MD direction is reported.5
25.8 kg
(56.9 lbs)6
Resistance
to Linting

are counted using a laser particle counter. Results are
expressed as the average number of lint particles generated
greater than 10 microns in size.7
Lower numbers in
this test indicate
less lint, which is
desirable in the
operating room
environment.
2 particles6
Hydrostatic
Pressure

observed on the underside of the fabric, the amount of
water in the column is measured. Results are expressed
in millibar (mbar) of water pressure a fabric can repel
before leaking.8
A higher number
indicates greater
resistance to water
penetration.
109.4 mbar6
Flammability

by the National Fire Prevention Association (NFPA) for
fabrics used for clothing:

time) indicates a
more flame
resistant fabric.
1 The
Kimberly-Clark*
6 Test
data generated by Integrated Paper Services, Neenah, WI via request # 9051.

9 NFPA 702-1980. Flammability of wearing apparel.
7
Kimberly-Clark*
Physical Properties Test Methodology and Results for KIMGUARD*

Test
Methodology
Interpretation
of Results
KIMGUARD*
KC100
Sterilization
Wrap Results1
BFE

Higher numbers in
this test indicate
better barrier
efficiency.
96.2 %4
Grab Tensile
The force required to break the fabric - grab tensile load indicate a stronger
- is measured. Results are reported as pounds of force fabric.
required to break the fabric. The lower result of CD or
MD direction is reported.5
5.71 kg
(12.6 lbs)6
Resistance
to Linting

minutes. Particles generated during the test period are
counted using a laser particle counter. Results are
Lower numbers in
this test indicate
less lint, which is
desirable in the
operating room
environment.
3 particles6
Hydrostatic
Pressure

A higher number
indicates greater
resistance to water
penetration.
46.4 mbar6
Flammability

A lower class (longer

time) indicates a
fabric.
Class 1 (30 sec.)6
1 The above results are averages based upon testing of representative samples selected randomly from distribution. Since KIMGUARD*
sterilization wrap consists of one layer, all testing was conducted on one layer. Two layers have been validated for wrapping.
Kimberly-Clark*
.
Kimberly-Clark*

Test
Methodology
Interpretation
of Results
KIMGUARD*
KC200
Sterilization
Wrap Results1
BFE

Higher numbers in
this test indicate
better barrier
efficiency.
96.7 %4
Grab Tensile
The force required to break the fabric - grab tensile load indicate a stronger
- is measured. Results are reported as pounds of force fabric.
required to break the fabric. The lower result of CD or
MD direction is reported.5
6.48 kg
(14.3 lbs)6
Resistance
to Linting

Lower numbers in
this test indicate
less lint, which is
desirable in the
operating room
environment.
2 particles6
Hydrostatic
Pressure

A higher number
indicates greater
resistance to water
penetration.
53.7 mbar6
Flammability


time) indicates a
fabric.
Kimberly-Clark*
.
Kimberly-Clark*

Test
Methodology
Interpretation
of Results
KIMGUARD*
KC300
Sterilization
Wrap Results1
BFE

Higher numbers in
this test indicate
better barrier
efficiency.
99.1 %4
Grab Tensile
7.8 kg
(17.2 lbs)6
Resistance
to Linting

Lower numbers in
this test indicate
less lint, which is
desirable in the
operating room
environment.
1 particles6
Hydrostatic
Pressure

A higher number
indicates greater
resistance to water
penetration.
58.9 mbar6
Flammability


time) indicates a
more flame
resistant fabric.
Kimberly-Clark*
.
Kimberly-Clark*

Test
Methodology
Interpretation
of Results
KIMGUARD*
KC400
Sterilization
Wrap Results1
BFE

Higher numbers in
this test indicate
better barrier
efficiency.
99.7 %4
Grab Tensile
11 kg
(24.3 lbs)6
Resistance
to Linting

Lower numbers in
this test indicate
less lint, which is
desirable in the
operating room
environment.
0 particles6
Hydrostatic
Pressure

A higher number
indicates greater
resistance to water
penetration.
62.1 mbar6
Flammability

Class 4: Dangerously flammable fabrics which have a f
lame spread time of less than 3 seconds.

time) indicates a
fabric.
Kimberly-Clark*
.
Kimberly-Clark*

Test
Methodology
Interpretation
of Results
KIMGUARD*
KC500
Sterilization
Wrap Results1
BFE

Higher numbers in
this test indicate
better barrier
efficiency.
99.5 %4
Grab Tensile
12 kg
(26.6 lbs)6
Resistance to In a controlled environment, a 9"X9" sample of fabric

Linting
Lower numbers in
this test indicate
less lint, which is
desirable in the
operating room
environment.
1 particles6
Hydrostatic
Pressure

A higher number
indicates greater
resistance to water
penetration.
79.1 mbar6
Flammability


time) indicates a
fabric.
Kimberly-Clark*
.
Kimberly-Clark*
Appendix 3: Chemical properties

Properties
Specification
Nr. of Layers
KIMGUARD KIMGUARD KIMGUARD KIMGUARD KIMGUARD

KC100
KC200
KC300
KC400
KC500
2
pH
EN ISO 868-2: 2009

ISO 6588-2
7.8
7.7
7.7
7.2
7.2
Colour Leach
EN ISO 868-2: 2009

ISO 6588-2
No Leach
No Leach
No Leach
No Leach
No Leach
%Sodium
Chloride
(p-value)
EN ISO 868-2: 2009

ISO 9197-1
<0.005
<0.005
<0.005
<0.005
<0.005
%Sodium
Sulphate
(p-value)
EN ISO 868-2: 2009

ISO 9198
<0.005
<0.005
<0.005
<0.005
<0.005
None
None
None
None
None
Fluorescence EN ISO 868-2: 2009

DIN 58953-6
References
Centexbel Summary :MG/HS07, 7094, 7195
Report Number MG/HS07
Kimberly-Clark*
Appendix 4: Ethylene Oxide sterilant penetration and residuals study results for KIMGUARD* and
KIMGUARD ONE-STEP* sterilization wrap
Purpose
KIMBERLY-CLARK* KIMGUARD* and KIMGUARD ONE-STEP* Wrap were validated for use with EO sterilization
to a sterility assurance level (SAL) of 10-6 using the BI overkill method. Additionally, residual levels of EO and
ECH were determined.
Test samples
AAMI challenge test packs were assembled per AAMI ST41:1999 section 7.6.1. Each test pack contained four
cotton surgical towels, one 25 cm (10 inch) length of latex tubing, one PVC airway, two biological indicators
inside needle-less 10 mL syringes and two chemical integrators and were wrapped with KIMGUARD ONE-STEP*
or KIMGUARD* Sterilization Wrap using the envelope fold.
The following models of KIMGUARD* and KIMGUARD ONE-STEP* Wrap were tested:
KC100 KIMGUARD* and KIMGUARD ONE-STEP*
KC600 Kimguard* and Kimguard One-Step*
This study consisted of a bracket approach for sterilant penetration determination for the KIMGUARD* and
KIMGUARD ONE-STEP* Sterilization Wrap product line. Since the testing was completed for the heaviest
and lightest weight models (KC100 respectively), as well as for the mid-weight model (KC400), this testing is
representative of all models of the KIMGUARD* and KIMGUARD ONE-STEP* wrap as follows: KC100, KC200,
KC300, KC400 and KC500.
Test methodology
The packages wrapped with KIMGUARD* and KIMGUARD ONE-STEP* KC100 and KC400 were sterilized using
100% EO with a concentration of 725-735 mg/L at 131F/ 55C and 40% - 80% relative humidity. The exposure
time tested was 30 minutes, which is half of the standard hospital cycle for these conditions. Immediately
following exposure, the biological indicators were cultured for sterility.
After the half cycle was confirmed by at least three runs, another set of wrapped packages were exposed to
full cycles (60 minutes). Immediately following sterilization (0 hours aeration), the packs were tested for the
amount of residual EO and ECH. Additional packages were allowed to aerate for more typical time conditions
(8 hours at 55C and 12 hours at 43.3C) and then tested.
Test results
Biological indicator (BI) culture results from the half cycle determination runs show that all packs tested were
sterile after an exposure time of 30 minutes. The results of the sterility testing are presented in the table below,
as the number of sterile packages out of the total number of packages tested:
Wrap Model
Number of sterile packages at 30 minutes exposure time in 100%

EO with a concentration of 725-735 mg/L at 131F/ 55C and
40% - 80% relative humidity
KC100 KIMGUARD ONE-STEP*
35 of 35
35 of 35
KC100 KIMGUARD*
35 of 35
KC400 KIMGUARD*
35 of 35
Kimberly-Clark*
As shown below, residuals analysis, after wrapped packages were exposed to full cycles (60 minutes), shows
that, even with no aeration, the wrap is well below the ANSI/AAMI/ISO 10993-7:1995/(R) 2001 requirements of:
less than 20 mg EO and
less than 12 mg of ECH.
Aeration KIMGUARD One-Step*
time and
KC100
temperature
EO(mg) ECH(mg)
Contents of KC100 Pack

PVC airway
Latex Tubing
Towel
EO(mg)
ECH(mg)
EO(mg)
ECH(mg)
EO(mg)
ECH(mg)
0 hours
0.215
0.151
5.564
0.024
13.991
0.128
0.606
5.220
8 hours,
55 (4)C
0.299
0.192
0.724
<0.023
0.023
0.026
0.471
3.367
12 hours,
43.3 (5)C
0.191
0.191
0.651
0.023
0.014
0.015
0.353
2.723
Aeration KIMGUARD One-Step*

time and
KC400
temperature
EO(mg) ECH(mg)

PVC airway
Latex Tubing
Towel
EO(mg)
ECH(mg)
EO(mg)
ECH(mg)
EO(mg)
ECH(mg)
0 hours
0.328
0.746
4.697
0.023
6.936
0.102
0.427
3.624
8 hours,
55 (4)C
0.356
0.356
0.637
<0.023
0.012
0.012
0.416
2.603
12 hours,
43.3 (5)C
0.301
0.262
0.775
<0.023
0.023
0.015
0.410
3.803
Aeration
time and
temperature
KIMGUARD*
KC100

PVC airway
Latex Tubing
Towel
EO(mg)
ECH(mg)
EO(mg)
ECH(mg)
EO(mg)
ECH(mg)
EO(mg)
ECH(mg)
0 hours
0.197
0.197
4.43
<0.023
6.79
0.086
0.415
3.61
8 hours,
55 (4)C
0.227
0.227
0.573
0.023
0.034
<0.012
0.639
3.00
12 hours,
43.3 (5)C
0.186
0.186
0.559
0.023
<0.012
<0.012
0.245
3.26
Kimberly-Clark*
Aeration
time and
temperature
KIMGUARD*
KC400

PVC airway
Latex Tubing
Towel
EO(mg)
ECH(mg)
EO(mg)
ECH(mg)
EO(mg)
ECH(mg)
EO(mg)
ECH(mg)
0 hours
0.358
0.358
4.33
<0.023
7.03
0.086
0.562
4.73
8 hours,
55 (4)C
0.339
0.339
0.427
<0.023
0.012
<0.012
0.882
0.973
12 hours,
43.3 (5)C
0.488
0.329
0.465
0.023
0.022
0.012
1.08
1.15
Conclusions
The validated EO cycle for KIMGUARD* and KIMGUARD ONE-STEP* KC100 and KC400 is for 100% EO with
a concentration of 725-735 mg/L at 131F/ 55C and 40% - 80% relative humidity for 60 minutes, with aeration
consisting of 8 hours at 55 C or 12 hours at 43.3 C. (The half cycle was determined to be 30 minutes at the
previously mentioned conditions.) Additionally, residuals analysis shows that, even with no aeration, the wrap
is well below the ANSI/AAMI/ISO 10993-7:1995/(R) 2001 requirements of less than 20 mg EO and less than
12 mg of ECH.
KIMGUARD ONE-STEP* Sterilization Wrap product line.
References
Nelson Laboratories Protocols: 200803407 REV 01, 200900091 REV 01
Nelson Laboratories Reports: 455561, 457003, 457004, 458664, 458666, 458667
Kimberly-Clark*
Appendix 5: Pre-vacuum steam sterilant penetration study results for KIMGUARD* and KIMGUARD
ONE-STEP* sterilization wrap
Purpose
KIMBERLY-CLARK* KIMGUARD* and KIMGUARD ONE-STEP* Wrap were validated for use with pre-vacuum
steam sterilization to a SAL of 10-6 using the BI overkill method.
Test samples
AAMI challenge test packs were assembled per AAMI ST79:2006 section 10.7.2.1. Each test pack contained
sixteen approximately 40,6 x 66 cm (16 x 26 inch) cotton surgical towels, two biological indicators, and two
chemical integrators. The contents of each package wrapped with KIMGUARD ONE-STEP* sterilization wrap
were wrapped with one application of wrap using the simultaneous wrapping method with an envelope fold.
The contents of each package wrapped with KIMGUARD* sterilization wrap were wrapped with two sheets of
wrap using the sequential wrapping method with an envelope fold.
The following models of KIMGUARD* and KIMGUARD ONE-STEP* Wrap were tested:
KIMGUARD ONE-STEP* Sterilization Wrap product line. Since the testing was completed for the heaviest
and lightest weight models, as well as for the mid-weight model (KC400), this testing is representative of all
models of the KIMGUARD* and KIMGUARD ONE-STEP* wrap as follows: KC100, KC200, KC300, KC400 and
KC500.
Test methodology
The packages wrapped with KIMGUARD* and KIMGUARD ONE-STEP* KC100 and KC400 were sterilized using a
pre-vacuum steam cycle at 270F/132C. The exposure time tested was 0.5 minutes, which is less than half of
the standard hospital cycle for these conditions. Immediately following exposure (no drying time), the biological
indicators were cultured for sterility.
Test results
Biological indicator (BI) culture results show that all packs tested were sterile after an exposure time of 0.5
minutes at 270F/132C. The results of the sterility testing are presented in the table below, as the number of
sterile packages out of the total number of packages tested:
Wrap Model
Number of sterile packages at 0.5 minutes exposure time in a

pre-vacuum steam cycle at 270F/132C
30 of 30
30 of 30
KC100 KIMGUARD*
30 of 30
KC400 KIMGUARD*
30 of 30
Kimberly-Clark*
Conclusions
KIMGUARD* and KIMGUARD ONE-STEP* KC100 and KC400 Sterilization Wraps are validated for use with
pre-vacuum steam sterilization at 270F/132C for 4 minutes. (The half cycle was determined to be 0.5 minutes
at the previously mentioned conditions.) This study consisted of a bracket approach for sterilant penetration
determination for the KIMGUARD* and KIMGUARD ONE-STEP* Sterilization Wrap product line. Since this
cycle is valid for the heaviest and lightest weight models (KC100 respectively) and was confirmed by including
the mid-weight model (KC400), this cycle is valid for all models of the KIMGUARD* and KIMGUARD ONE-STEP*
wrap as follows: KC100, KC200, KC300, KC400 and KC500.
References
Nelson Laboratories Protocols: 200800957 REV 02, 200800958 REV 01
Nelson Laboratories Reports: 420406, 420410, 420416, 430208, 432434, 431529
Kimberly-Clark*
Appendix 6: Basis weight of materials not requiring conditioning

The test samples where 161.29 cm2 (25 in2) in size.
KC100
seq
KC100
OS
KC200
seq
KC200
OS
KC300
seq
KC300
OS
KC400
seq
KC400
OS
KC500
seq
KC500
OS
AVG
BW g/
m
138.78
70.33
40.58
80.44
46.36
92.34
62.25
123.73
69.46
138.78
STD
2.67
2.37
0.62
1.19
1.09
1.26
1.42
1.89
1.34
2.67
%CV
References
STM 2600 Basis Weight of Materials Not Requiring Conditioning
Kimberly-Clark*
Appendix 7: Executive summary colorfastness study for KIMGUARD ONE-STEP* sterilization wrap
Each model of KIMGUARD ONE-STEP (KC100-KC600) was tested while non-sterile and after sterilization by
pre-vacuum steam and ethylene oxide for colorfastness of the ink used to indicate the model, lot number, and
size along one bonded edge.
Integrated Paper Services (Appleton, WI) performed the colorfastness test according to AATCC 8-2007 and
evaluated the samples against a gray scale described in the standard. The gray scale ranges from 1-5 with 1
being the lowest amount of ink transfer onto a muslin sheet and 5 being the highest amount of ink transfer.
Ten (10) samples were tested for each model and each of the sterilization methods (including non-sterile). Nonsterile samples for testing were prepared by the materials evaluation department at Kimberly-Clark. Sterile
samples were prepared from wraps sterilized at Nelson Labs (Salt Lake City, UT) using one of the following
sterilization cycles:
Sterilization Method
Sterilization Parameters
Pre-vacuum steam sterilization
Exposure: 132C (270F) for 4 minutes;

Dry time: 20 minutes
EO sterilization
Exposure: 100% EO with a concentration of 725

mg/L at 54-55C and 40% - 80% relative humidity
for 60 minutes;
Aeration: 12 hours at 48C
Test results
Average results for each model and sterilization cycle are as follows:
Non-sterile
EO
Pre-vacuum Steam
KC100 ONE-STEP
1-2
1-2
1-2
KC200 ONE-STEP
1-2
1-2
1-2
KC300 ONE-STEP
1-2
1-2
1-2
KC400 ONE-STEP
1-2
1-2
1-2
KC500 ONE-STEP
1-2
1-2
1-2
Conclusions
These values indicate a small amount of ink transfer onto the muslin sheet for the wrap, both pre-sterile and
post-sterilization by pre-vacuum steam and EO. There was no change in the colorfastness of the ink caused by
the sterilization cycles. ISO 10993 biocompatibility testing was performed in a separate study on the sterilized
wraps with this ink, with no adverse test results.
References
Summary on file with KC.
Kimberly-Clark*
Appendix 8: Maintenance of package integrity study results for KIMGUARD* and KIMGUARD ONE-STEP*
sterilization wrap
Purpose
KIMBERLY-CLARK* KIMGUARD* and KIMGUARD ONE-STEP* Wrap were tested for performance in maintaining
the package integrity of sterilized wrapped packages for 30 days post-sterilization. Sterilization was performed
using either pre-vacuum steam at 270F/132C for 4 minutes or using 100% EO with a concentration of 725-735 mg/L
at 131F/ 55C and 40% - 80% relative humidity for 60 minutes.
Test samples
All models of KIMGUARD* and KIMGUARD ONE-STEP* Wrap were tested:


The table below indicates the package contents for each wrap model tested. Eight gauze stacks and one
biological indicator were included in each package. The gauze stacks were positioned between the wrap
and the package contents with four stacks on top and four on bottom and were used as the items for
sterility testing. The biological indicators were placed in the center of the packages and were used to
verify the sterilization cycle efficacy. The contents of each package wrapped with KIMGUARD ONE-STEP*
sterilization wrap were wrapped with one application of wrap using the simultaneous wrapping method
with an envelope fold. The contents of each package wrapped with KIMGUARD* sterilization wrap were
wrapped with two sheets of wrap using the sequential wrapping method with an envelope fold.
Test methodology
The wrapped packages were sterilized by either pre-vacuum steam at 270F/132C for 4 minutes or by
100% EO with a concentration of 725-735 mg/L at 131F/ 55C and 40% - 80% relative humidity for 60
minutes. Following sterilization and cooling or aeration, a designated number of packages (negative controls)
were immediately tested for sterility to assure sterilizer efficacy. Both the biological indicators and the
gauze stacks from the negative controls were cultured to assure sterilizer efficacy. Additional control
packs of each wrap type were utilized to verify that the contamination could be detected, to ensure that
wet packs (for pre-vacuum steam sterilization) were not a source of contamination in the study, and to
monitor bioburden levels throughout the study. After sterilization and cooling or aeration, the test packages
were removed from the sterilizer, underwent a series of handling and transport events based upon typical
sterile package handling practices in hospitals over a 3-day period, and then were stored under controlled
conditions simulating a hospital sterile storage environment. After 30 days of storage, representative sterilized
packages were tested for sterility, wherein the 8 gauze stacks were removed from each test package and
tested for the growth of microbial contaminants. The biological indicators from the test packages were also
cultured to assure sterilizer efficacy. The table below indicates the package contents for each wrap model
tested. Eight gauze stacks and one biological indicator were included in each package. The gauze stacks
were positioned between the wrap and the package contents with four stacks on top and four on bottom
and were used as the items for sterility testing. The biological indicators were placed in the center of the
packages and were used to verify the sterilization cycle efficacy. The contents of each package wrapped with
KIMGUARD ONE-STEP* sterilization wrap were wrapped with one application of wrap using the simultaneous wrapping
method with an envelope fold. The contents of each package wrapped with KIMGUARD* sterilization wrap
were wrapped with two sheets of wrap using the sequential wrapping method with an envelope fold.
Kimberly-Clark*
Table 1.
KIMGUARD* and
KIMGUARD ONE-STEP*
Sterilization Wrap
Models
Intended Loads
Maximum Wrapped
Descriptions of Loads
Package Content
Used in Sterility
Weights Used in Sterility Maintenance Validation
Maintenance Validation
Study
Study
KC100
Very light weight package

(for example: towel packs)
1.36 kg (3 lbs)
16 huck towels (17x 29)

(43 x 73.6 cm)
KC200
Light weight package (for

example: standard linen packs)
2.7 kg (6 lbs)
2 huck towels
(17x 29) (43 x 73.6 cm)
2 fluid resistant U-drape
(68x109) (172.7 x 276.8 cm)
1 fluid resistant universal
bar drape (70 x 108)
(177.8 x 274.3 cm)
KC300
Light to moderate weight

package (for example: general
use medical instruments)
4 kg (9 lbs)
For Pre-Vacuum Steam:

15 huck towels
(17x 29) ( 43 x 73.6)
1 small fluid resistant drape
(60x 76) (152.4 x 193 cm)
5 lbs (2.26 kg) of metal mass
For EO:
16 huck towels
2 fluid resistant large drapes
(76x100) (193 x 254 cm)
1 fluid resistant small drape
(76x60) (193 x 152.4 cm)
1 fluid resistant table cover
(60x 90) (152.4 x 228.6 cm)
KC400
Moderate to heavy weight

package (for example: general
use medical instruments)
5.9 kg (13 lbs)
4 tray liners (20 x 25)

(50.8 x 63.5 cm) stacked
(10 x 10 x 3 )
(25.4 x 25.4 x 8.9 cm)
tray containing 11 lbs
(4.98 kg) of metal mass
KC500
Heavyweight package (for

example: general use medical
instruments)
7.7 kg (17 lbs)
4 tray liners (20 x 25)

(50.8 x 63.5 cm) stacked
(10 x 10 x 3 )
(25.4 x 25.4 x 8.9 cm)
tray containing
15 lbs (6.8 kg) of metal
mass
Kimberly-Clark*
Test results
The results of the sterility testing are presented in the table below, as the number of packages with no microbial growth
out of the total number of packages tested:
Wrap Model
Pre-Vacuum Steam (Number of

packages with no growth)
EO (Number of packages
with no growth)
10 of 10
10 of 10
10 of 10
10 of 10
10 of 10
10 of 10
10 of 10
10 of 10
10 of 10
10 of 10
KC100 KIMGUARD*
10 of 10
20 of 20
KC200 KIMGUARD*
10 of 10
10 of 10
KC300 KIMGUARD*
10 of 10
10 of 10
KC400 KIMGUARD*
10 of 10
10 of 10
KC500 KIMGUARD*
10 of 10
10 of 10
Conclusions
When sterilized with either pre-vacuum steam (at 270F/132C for 4 minutes) or EO (using 100% EO with a concentration of 725-735 mg/L at 131F/ 55C and 40% - 80% relative humidity for 60 minutes), sterility of the package
contents was maintained for 30 days post-sterilization for all models of KIMGUARD* and KIMGUARD ONE-STEP*
Sterilization Wrap.
References
LexaMed Reports: 08-L046, 08-L047, 08-L048, 08-L049, 08-L088, 08-L089, 08-L090, 08-L091, 08-L129, 08-L130, 08-L131, 08L-132, 09-L001, 09L024
The Kimberly-Clark Advantage*

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healthcare solutions that you can
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fast-paced world, supported by in-service
training, clinical research and education.
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Kimberly-Clark solutions, youll have
one less worry.

Knowledgeable Customer Support
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Product technical support
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Product Use and Selection Tools
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Exam Glove Space & Waste calculator
Latex-Free Exam Glove Community Outreach program
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Kimberly-Clark NV/SA
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Tel: +32 2 711 26 00
Fax: +32 2 711 26 90
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Kent, ME19 4HA, United Kingdom
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ISO 11607-1 2006 Reference

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ISO 11607-1 2006 Reference

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Kimberly-Clark*

Kimguard* Sterilization Wrap .

1.1 Quality systems

2. Materials and preformed sterile barrier systems

2.1 General requirements

2.5 Storage and transport

Appendix 1: ISO 9001

** Prepared by H. Prokash, Senior Research

Association for the Advancement of Medical Instrumentation

AATCC : American Association of Textile Chemists and Colorists

American National Standards Institute

ASTM : American Society for Testing and Materials

Bacterial Filtration Efficiency

CD tear : Cross Direction

Deutsches Institut fr Normung

First In First Out

Flexible Test and Measurement System

International Nonwovens and Disposables Association

International Organization for Standardization

International Standard Test

MD tear : Machine Direction

National Fire Prevention Association

Measure of the acidity or alkalinity

Sterility Assurance Level

Sterile Barrier System

Standard Operating Procedures

Kimguard* Sterilization Wraps

See appendix 1: ISO 9001:2008 Certificate

1.3 Test methods

ISO 6588, hot extraction method

INDA Standard test IST 160.1 (01)

Bursting Strength (dry)

Bursting Strength (wet)

MD Tensile Strength (dry)

CD Tensile Strength (dry)

MD Tensile Strength (wet)

CD Tensile Strength (wet)

ISO 6588-2, hot extraction method

ISO 9197-1, hot extraction method

Sodium Chloride content

ISO 9198, hot extraction method

Sodium Sulphate content

5514 FTMS No. 191A, INDA 80.4 -92

Hydrostatic Head Pressure

Bacterial Filtration Efficiency

2. Materials and preformed sterile barrier systems

d) maximum rate of change of the above, where necessary

See paragraph 2.1.5.d.

See appendix 2: Physical properties

b) biocompatibility and toxicological attributes

See appendix 2: Physical properties

d) compatibility with respect to forming and sealing processes

See appendix 4: EO sterilization

f) any shelf-life limitations for pre-sterilization and post-sterilization storage

See appendix 3: Chemical properties

See appendix 6: Basis Weight of Materials Not Requiring Conditioning

See appendix 2: Physical properties

See appendix 2: Physical properties

See appendix 3: Chemical properties

2.2 Microbial barrier properties

See appendix 2: Physical properties

2.3 Compatibility with the sterilization process

See paragraph 2.1.4 e.

See paragraph 2.1.5.e.